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Biotech Startups in India -

At the Cusp of Global Impact

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Contents

A VIBRANT ECOSYSTEM AND THE BOTTOM-UP REVOLUTION ....................................................... 1

ERA 1.0: LAYING A STRONG FOUNDATION FOR THE BIOTECH STARTUP ECOSYSTEM .......... 4

1.1 EXTRAMURAL GRANTS FOR VENTURES ..................................................................................................... 4

1.2 INITIATIVES ADDRESSING STRUCTURAL GAPS: ......................................................................................... 5

1.3 CONTINUED PRIMING OF THE ECOSYSTEM WITH NEWER INITIATIVES ....................................................... 6

ERA 2.0: OVERVIEW OF THE CURRENT LANDSCAPE ......................................................................... 10

2.1 GENESIS OF TECHNOLOGY & DNA OF ENTREPRENEURS ....................................................................... 10

2.2 EMERGENCE OF REGIONAL CLUSTERS & IMPROVED INFRASTRUCTURE ................................................ 11

2.3 FUNDING .................................................................................................................................................... 13

2.4 AREAS OF INNOVATION ............................................................................................................................. 15

ERA 3.0: RECOMMENDATIONS FOR TRIGGERING GLOBAL IMPACT ........................................... 20

3.1 FOSTERING MORE ROBUST PIPELINE OF DEEP SCIENCE DRIVEN STARTUPS ....................................... 20

3.2 ADDRESSING GLARING VOID IN SCALE-UP FUNDING .............................................................................. 21

3.3 CONTINUING INFRASTRUCTURE CHALLENGES AT SCALE-UP STAGE ..................................................... 24

3.4 CREATING REWARD FOR INNOVATION AND FOSTERING MARKET MATURITY ......................................... 25

3.5 EASE OF DOING BUSINESS ....................................................................................................................... 27

ABBREVIATIONS ............................................................................................................................................. 32

A Vibrant Ecosystem and the Bottom-up Revolution

1


We are delighted to analyze state of biotechnology innovation in India with emphasis on early

stage innovation and its acceleration. Over the last five years, Indian ecosystem for early

stage biotech innovation and startups has gained significant momentum. Over 500 ventures

have attempted to expand boundaries of science, pursue novel therapies, diagnostics, devices

and industrial solutions, with surge in investment in early stage ventures. Robust clusters in

Bengaluru, Pune, and Hyderabad etc. have converged biotech ventures and academic

centers of excellence to co-create products and services, applying most cost-effective

innovation frameworks. Since early stage ventures entail classic high-risk–high reward

dichotomy, it is essential for Government to deploy significant level of risk funding to propel

innovation. To a large extent, innovation investment support for pre-seed stage has witnessed

significant surge due to Department of Biotechnology (DBT) and associated institutions

committing early de-risking investments to hundreds of ventures.

Translational platforms such as the National Bio design Alliance (NBA), conceived, catalyzed

and funded by DBT has evolved as a unique model of innovation convergence, transcending

traditional boundaries of numerous research disciplines within the public research system.

With demonstrated buy-in within IITs and national health research organizations, NBA has

emerged as a pioneering and unique national alliance to address critical national needs in

human health. Some of the ventures germinating from the NBA ecosystem are moving through

progressive rounds of funding, thus duly establishing credentials of this model of convergent

growth of start-ups around the academic eco-system.

However, there are number of areas that needs targeted focus, to enlarge and effectively

sustain innovation in the start-up ecosystem. The thrust of the Prime Minister on “Make in

India” is dependent on “Innovate in India”. Life sciences provide the most promising

opportunities for early stage innovation and for India to emerge at the forefront of the

innovation pathway, we need to consider flow of resources intended for the “Innovate in India”

imperative to percolate to the life sciences innovation ventures. The resources earmarked for

Innovation acceleration through the fund of funds has hardly reached the peripherals of life

sciences ventures and have gone into information technology and other sectors. The reason

is partly the inability to perceive the risk of investing in the life science sector. We need to gain

a large surge of investment for acceleration of these innovations. We need to see significantly

larger investment in ecosystem enlargement, as startups converge at a rapid pace in bio-

clusters. We would like to see deeper convergence of the academic technologies into the

private ventures with a policy framework that encourages academic spin-outs and technology

flow to early stage innovators. Finally, we need public procurement to support and absorb

these innovations with a policy that encourages affordable products to be taken to market

without bureaucratic hurdle.


2


3

Era 1.0 : Laying a Strong

Foundation for the Biotech

Startup Ecosystem

Laying a Strong Foundation for the Biotech Startup Ecosystem

4

Era 1.0: Laying a Strong Foundation for the Biotech Startup Ecosystem

The last decade has been transformational for the Indian biotech and medtech startup

ecosystem. While several biotech ventures such as Biocon, Bharat Biotech, Biological E and

Shanta Biotech among others, were seeded prior to that and have been nurtured into

formidable industry players, biotech startups were not a widespread phenomenon. There were

less than twenty scaled up success stories that charted unique paths primarily led by their

founders’ determination to navigate unpaved terrain. Early government innovation funding

programs such as TDB and NMITLI provided thin lifelines in an otherwise nascent ecosystem.

Role models were far and few for aspiring entrepreneurs, access to forgiving capital to

shoulder technology risk was a challenge, equity capital to defray market risks was also hard

to raise.

We now stand at a threshold of explosion with more than 500 ventures passionately advancing

innovation to markets. This surge is not ephemeral because it is anchored in foundational

changes led by design and supported by ecosystem tailwinds. The product IP regime

introduced in 2005 in India was a major fillip for this wave of change. Pioneers such as Dr

Mashelkar motivated several corners of the research system to go beyond publishing to

patenting and thus, translational research. The institutional backbone was primed. Pioneered

by DBT under Dr Bhan’s vision, Government funding for ventures was geometrically expanded

and extra-mural funding that can de-risk technology became a more tangible lifeline. BIRAC

alone, through its several vectors has supported 617 projects that have filed closed to 150

patents as of September 2017.1 Biotech innovation does not function in silos and convergence

is critical for the symphony to function. The ecosystem lens was adopted, and collaboration

platforms created to propel a culture of co-creation. Key elements of change that have

contributed to the current fertile ground for biotech and medtech entrepreneurship include:

1.1 Extramural Grants for Ventures

Technology de-risking seed capital providing runway to take-off: Globally, public funding

has been the most common starting point of biotech and medtech innovation, and has been

instrumental in supporting initial proof of concept stages. This is especially true in ventures

advancing innovations with deep rooted science. At this stage, technology risk is highest and

probability of success is hard to determine. As progressive stages of proof of concept is

established, technology risk reduces and equity capital becomes more accessible.

Significant component of public funding for research in India has traditionally been directed

towards public research labs as intramural funding. The quantum leap in level of extramural

funding programs such as SBIRI, BIPP and BIG has been one of the most significant

stimulants for the entrepreneurship wave. It has empowered several aspirational

entrepreneurs to pursue early proof of concept and embark on the startup journey. BIRAC

alone has provided funding of close to INR 850 crores as of September 20172 and this stimulus

has been pivotal in creating the base of the startup funnel. In addition to providing seed money,

grants like BIG facilitate mentoring and monitoring through a diverse board of scientists and

business veterans. Support in handholding for IP and technology management, capacity

building, and stitching partnerships with other grant recipients allows ventures to expedite

growth on the right tangents. This availability of grant funding has resulted in a cyclic effect

with ventures being triggered and the resultant momentum leading to interest from other

1,2 BIRAC Innovations: Propelling the Bio-economy Report, 2017


5

philanthropic and science funders (The Bill and Melinda Gates Foundation, The Wellcome

Trust to name a few) who have further expanded the pool of early stage non-dilutive funding.

1.2 Initiatives Addressing Structural Gaps:

Creating platforms for convergent innovation and seeding national pipeline: India has a

strong institutional backbone at universities and national research networks such as CSIR,

ICMR and ICAR. These academic institutions are at the base of the innovation pyramid and

offer the most fertile platform for pursuit of research in multi-disciplinary areas such as medical


6

devices and diagnostics. However, translation of existing institutional strength into innovation

pipeline with commercial potential has been restrained because of characterized silos. For

instance, most leading US universities house high research strengths across engineering,

biochemistry, microbiology, informatics and clinical delivery within one campus with several

opportunities for identification of unmet needs and organic convergence of multi-disciplinary

teams for creation of solutions. In the Indian context, same fluid innovation flow is not

observed given the siloed presence of clinical pioneers, leading engineering colleges and

basic science institutions. While forerunners such as SCTIMST in Trivandrum have developed

complex Class III devices, such innovation engagement in medtech hasn’t been a widespread

phenomenon due to this structural issue in organization of research institutions.

Another foundational aspect in the last decade has been conceptualization and creation of

translational platforms that have converged multi-disciplinary expertise to co-create nationally

and globally relevant solutions. In addition to triggering a national pipeline of devices and

diagnostics and demonstrating model of engagement in multi-disciplinary innovation

advancement, these platforms have nurtured a deeper culture of convergent innovation across

the ecosystem. A high impact example of such translational platforms is the National

Biodesign Alliance created by the DBT that converged leading clinical and research institutions

in thematic areas of focus (illustrated below). Programs within the platform have now resulted

in multiple technologies being licensed and spun out into ventures and the models are now

being emulated by other institutions.

1.3 Continued Priming of the Ecosystem with Newer Initiatives

Startup momentum in the biotech and medtech segment is further strengthened by new

initiatives that have the potential to expand opportunities and support value realization:

1.3.1 Start-Up India

The Start-Up India campaign launched in 2016, has been one of the most prominent steps

taken towards promulgating culture of organized and rewarded innovation in India. It includes

a fund of funds corpus of INR 10,000 crore, tax exemptions, rebates in patent filing and

business self-certification. The program is gaining traction with number of registered

companies increasing from 4536 registered companies in October-17 to 5350 in December-

National Biodesign Alliance


7

17.3 Overall momentum in the entrepreneurial community has been enhanced, and if funneled

strategically, funding and other benefits can bridge current gaps and support further evolution

of this ecosystem.

1.3.2 Biotech parks with shared facilities

Bioincubation needs specialized infrastructure.

Shared infrastructure platforms with well-

structured access models for critical equipment

provide soft landing avenues for startups and

significantly reduce initial investment. There has

been substantial expansion in bioincubation

space both in major hubs such as Bengaluru, Hyderabad, Delhi, Pune and emerging ones

such as Coimbatore, Kanpur, Trivandrum. Ease of access to incubation space and equipment

has been a key driver propelling momentum in ventures.

1.3.3 Corpus funds and incubation funding platforms

Incubators and accelerators provide more than

brick and mortar to ventures. Services on legal

and regulatory hurdles, shared tinkering &

prototyping labs, and a collaborative

knowledge network for fellow incubatees

enable innovation creation and dissemination.

A major initiative championing the movement

has been funding for incubators from NITI Ayog

under the Atal Innovation Mission, BIRAC

under BioNest, DST under TDB and NIDHI

PRAYAS. Additional fillip is anticipated from

BIRAC’s $250 million innovate in India (i3) programme that has been launched in collaboration

with the World Bank.

1.3.4 Policy and regulatory thrust

There has been proactive engagement by policymakers with industry to address gaps,

strengthen regulatory frameworks and simplify processes. Significant developments include

introduction of the Medical Device Rules, new biosimilar guidelines, addressing inverse duty

structure in certain medical device products. Continuing focus on ease of doing business and

refinement of regulatory frameworks are promising for innovation ecosystem that is at the

threshold of breaking into the next realm of growth.

3 Status Report on Startup India- www.startupindia.gov.in

Incubators/infrastructure platforms:

TDB funded 36 TBIs and STEP

BIRAC funded 15 incubators with intent to

create another 50 by 2020

(Source: TDB.gov.in; BIRAC Brochure, 2016)

Birac’s i3 is a USD 250 million corpus

created as part of Biopharma Mission to fund

biotech startups and accelerate innovation in

the areas of vaccines, bio-therapeutics and

medical devices. With USD 125 million from

the World Bank and an equal contribution

from Government of India, the program will

fund companies to advance assets and other

capacity building efforts to address

infrastructure and skill gaps.


8


9

Era 2.0 : Substantial

Momentum and Surge in

Startup Activity

Substantial Momentum and Surge in Startup Activity

10

Era 2.0: Overview of the Current Landscape

The foundation laid by design has reaped substantial reward. The biotech and medtech

entrepreneurship wave is a reality and there is a surge of ventures both in dominant

geographic hubs and emerging ones. The current Era 2.0 presents a vibrant landscape where

both socially relevant and globally opportune solutions are being passionately pursued. Even

while being driven by a common motto, each venture can be traced to a different interplay of

genesis, geography and trajectory:

2.1 Genesis of Technology & DNA of Entrepreneurs

There is no mantra that safeguards success of a venture, but ideas and people are two key

components of the equation.

Reiterating the fact, today ventures

can access non-dilutive grants more

readily across stages of idea

exploration, proof of concept and

validation, which has enabled

technology de-risking. This

continues to prompt the rise of first

generation entrepreneurs, to step

out of secure jobs and take the

entrepreneurial plunge. There is no

pecking order but there is now

notable engagement in the

ecosystem from industry veterans

with several years of experience in

R&D, expats either coming back to

set up Indian ventures or founding

ventures that have an Indian

presence, recent graduates from

leading Indian and global institutions

as well as faculty involved in institutional research. The accompanying graph indicates the

equitable distribution of innovators from different backgrounds from three largest incubation

centers in the country.

The number of spin-out ventures commercializing research with genesis in Indian institutions

comprise a lower proportion of the overall startup landscape as compared to more mature

innovation ecosystems. However, culture of collaboration is actively expanding, and ventures

are increasingly leaning on institutions to leverage depth of scientific expertise. As translational

focus expands and evolves, there is significant potential for institutions to emerge as a potent

source of venture creation. An example of a spin-out from an academic institution with

relatively deeper engagement in applied research is PathShodh Healthcare.

33%

15%

52%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Others (Recent Graduates etc.) Expats Industry Veterans


11

2.2 Emergence of Regional Clusters & Improved Infrastructure

Biotechnology innovation is often a relay with several stakeholders steering innovation forward

at various stages and a team game with co-creation often being invaluable. Consequently, it

needs a co-evolving network of institutes, companies, universities, service providers and

private capital to thrive. Prominent global hubs are living examples of organic clustering

common in this segment and its impact on increased probability of success. Examples include

startup and innovation clusters around San Francisco Bay Area supported by Silicon Valley,

pioneering biotech companies such as Amgen and Genentech and abundant venture capital;

Boston Biopharma cluster supported by presence of institutional backbone with

Massachusetts Institute of Technology, Harvard, Massachusetts General Hospital, large

pharma companies like Sanofi, Pfizer, Novartis, and the Minneapolis Medical devices hub led

by giants like Medtronic.

Similar factors have led to concentration of technologies and innovation in and around certain

regions in India, which have now emerged as megaclusters. Karnataka, for instance, has

enjoyed strong applied science depth in institutions and the State Government’s venture

capital fund has provided additional boost for startups. Existence of larger biotech companies

such as Biocon has also resulted in a vibrant research landscape and has seeded next

generation of entrepreneurial scientists. Encouraging presence of global development centers

of MNCs like GE and Philips in the state has also resulted in more experienced entrepreneurs

emerging from these companies and adding to activity concentration and value enhancement

in the cluster.

Therefore, congruous factors like large corporates, other successful ventures, incubation

infrastructure and policy initiatives have contributed to geographical consolidation, creating

three large biotech nuclei: Bengaluru, Hyderabad and Pune.

PathShodh Healthcare: Example of an Institutional Spinout

A spin out of IISc Bengaluru, PathShodh is focused on relatively more upstream R&D within

PoC diagnostics. The startup co-founded by Navkanta Bhat, Vinay Chauhan and Gautam

Sharma, has largely leveraged grants such as BIPP to advance to current stage of

development. PathShodh Healthcare, has developed a patented biosensor device that

monitors diabetes management and enables early detection of chronic kidney disease. The

miniaturized patented device is targeted at clinics and hospitals in the rural and tier II cities

with subsequent plans for home use.


12

Percentage of BIG supported projects upto 8th Call (Source: BIRAC BIG Book 2016)

Bengaluru: Bengaluru has relatively higher number of startups, a notable concentration in

diagnostics and medical devices and a higher (than national average) concentration of

ventures founded by entrepreneurs with prior industry experience. Continuing momentum

is fueled by abundant multi-disciplinary talent pool, active bio-entrepreneurship hubs such

as BIRAC funded C-CAMP, and State Government initiatives such as the Bangalore

Bioinnovation Center, a younger but active innovation hub in South Bengaluru, the Idea to

PoC grant and venture capital funding from the KITVEN fund.

Delhi/NCR: Within Northern India, the Delhi-Faridabad-Gurgaon region is an active hub

with significant innovation activity supported by stellar academic institutions including IIT

Delhi, AIIMS, ICGEB, NII, THSTI, RCB and incubation anchors such as FITT, IIT Delhi.


13

There has been a recent emergence of newer incubation centers and significant innovation

activity in locations such as Kanpur (UP), Trivandrum (Kerala), Bhubaneswar (Odisha).

However, considering the strong interdependence and open alliances required for success

within the biotechnology network, it is critical that concentration of engagement in emerging

clusters is deepened with focused effort.

2.3 Funding

For any biotech or medtech venture, there is a much higher technology risk in initial phases,

which transforms into higher market risk in subsequent phases. As technology risk is defrayed,

equity becomes more accessible from both financial and strategic investors. In the initial

stages, the entrepreneurial surge has been largely propelled by non-dilutive capital available

from DBT and other Government sources as well as philanthropic sources where there is

alignment of priorities. In recent years, bilateral and multilateral interaction has also given

ground to newer funding schemes. Funding opportunities such as Indo-US VAP, Indo-Swiss

and Indo-Finnish bilateral program have set a great precedence for collaboration, exposing

Indian public research to otherwise unexplored collaborative opportunities and fostering

programs with significant development.

As initial proof of concept is established, angel funding could serve as the critical next step

with several angel networks now being active in the country. However, angel investments

have been largely limited to diagnostics, devices and industrial biotechnology applications

where path to markets are shorter and there has been very limited angel participation in drug

discovery and development. As illustrated below, when ventures move towards the right on

the continuum of path to markets and technology risk gradually reduces, equity funding

becomes more tangible. In the Indian context, availability of equity funding has been easier

for medical devices and diagnostics ventures and again drug discovery ventures have greater

hardships finding first two rounds of equity capital with the appropriate risk profile.

Hyderabad: Concentration of large pharma and vaccine companies in the area and

availability of incubation space has shaped Hyderabad into a leading biopharma cluster.

T-Hub, IKP and academic institutes like IIT-H, University of Hyderabad, and LVPEI have

provided a nurturing ground for curating new ideas and supporting entrepreneurs. While

other clusters struggle with inadequacy of infrastructure for scale-up, availability of land

for commercial scale-up (in Genome Valley) is an additional pull for the hub.

Pune: Research backbone of institutions such as NCL, NIV, NARI, NCCS, and IISER

and active role played by the Venture Center (NCL) has provided fertile substrate for

biotech ventures. Additionally, proximity to Mumbai venture constellation and strong

presence of IT, agriculture and pharma advances ventures with multi-disciplinary focus.


14

Funding requirement varies across sub-segments for different phases of a start-up lifecycle.

A large fraction of ventures have been able to get USD 100,000 from BIG grant and depending

on the nature of the product, anywhere between USD 0.5 Million and USD 3.0 Million in

following rounds. In the case of medtech ventures with relatively lower investment

requirement, leading ventures have been able to raise up to USD 5.0 Million to USD 10.0

Million of equity capital for market launch and initial scale up. Conversely, the investment in

core science remains elusive despite the glaring unmet needs in the field. One of the few

examples of drug discovery startups that has raised rounds of venture capital funding is

Vyome Biosciensces:

Vyome Biosciences: Funding Success

The Delhi based startup, Vyome Biosciences, was founded in 2010. The company has

emerged from grassroots level as one of the promising startups in mainstream

biotechnology arena, backed by an adroit clinical expert team. Beginning with SBIRI

grant, followed by series A funding (USD 2.8 Mn) in 2012 and series B funding (USD

8 Mn) in 2014, the company touts a rich heritage of funding support. Enabled by strong

funding, the venture has completed phase I and proof of concept studies for their lead

product, which helps to cure moderate to serious acne. In 2016, Vyome secured series

C funding (USD 14 Mn) towards phase 2 clinical studies for FDA approval of the

product. The Company also boasts two patented novel platform technologies with a

strong pipeline of drugs for antibiotic resistant acne and other opportunistic pathogens.

Indian Funding Landscape across Startup Lifecycle


15

2.4 Areas of Innovation

Disruptive innovation has been the norm in several sectors but is only at the beginning of the

curve in healthcare. We have witnessed incremental innovation as well as bottom-up

technology creation across the biotech spectrum. The more pronounced areas of innovation

that have emerged in the last ten years are discussed below:

2.4.1 Innovations addressing critical national needs

In out of pocket markets such as India with significant unmet needs and inefficiencies in

healthcare, there is a rapid development of innovations catering to critical national needs

across devices as well as biopharma. However, coordinated national effort is required to

realize the potential and maximize public health impact.

Applied innovation in devices and diagnostics: To increase access and affordability of

healthcare, there has been a constant focus on incremental innovation, platform and product

innovation in medtech as well as diagnostics. This portfolio of innovation is expanding

applications with existing science and combining synergistic and interdisciplinary approaches

to address native public healthcare needs. Propelled by various philanthropic grant funding

opportunities, there is a robust pipeline of maternal and child healthcare solutions and point of

care diagnostics. There is also significant momentum around several ventures engaging in

devices that provide connected care and diagnostics that leverage intelligence and information

technology foundation to automate test interpretation, address skill-gaps, introduce efficiency

in continuum of care and simplify healthcare delivery.

Upstream drug discovery and development: India is burdened with high incidence of

diseases such as antibiotic resistance, diabetes and respiratory. As problems more

pronounced in developing countries such as India, these areas of drug discovery are not high

priority areas for multinational pharma countries headquartered in US or Europe. Hence, it is

critical that India nourishes its own pipeline of ventures seeking solutions to pressing needs in

the country.

Despite the high need, there is a relatively lower level of startup engagement in upstream

discovery and development of novel drugs and vaccines. Bugworks, Vitas Pharma and

Tergene Biotech are examples of pioneer ventures engaged in areas of drug or vaccine

development that has high level of relevance for India.

So

hu

m

The five year old venture developed under SIB, blends design innovation with auditory testing science BERA to bring an affordable and locally manufactured neonatal hearing screening device to diagnose congenital hearing loss in neonates for low resource settings.

Sig

Tu

ple

Riding the digitization wave, SigTuple, founded in 2015 by experts in Big Data Analytics, has developed automated microscope. Built on AI platform with image analysis capability for various diagnostic applications, the product eliminates the need for skilled medical experts for accurate diagnosis.


16

The high level of risk and investment involved, currently lower level of institutional spin-out

creation, dearth of entrepreneurs experienced in global context of drug discovery and

development and paucity of capital tend to be significant deterrents that need to be addressed.

2.4.2 Innovations catering to global markets

In addition to addressing India specific problems, several innovative ventures have pursued

solutions to globally relevant problems and are seeking global commercialization opportunities

from the outset. These ventures have been able to leverage the relatively lower cost of

development in India, build globally benchmarkable sophistication and move on the path of

seeking regulatory approvals from USFDA or EMA or strategic partnership opportunities with

US or European companies. Notable examples include medical device companies such as

Perfint Healthcare that has developed USFDA cleared robotic devices for image guided

interventional procedures, novel biomarker discovery companies such as Saarum Biosciences

and Transcell and drug discovery companies such as Connexios, Curadev and Rhizen that

have demonstrated merit of their program through global out-licensing deals.

2.4.3 Nextgen Innovations

Genomics: Genomics is the newest frontier in diagnostics and is scripting a required

paradigm shift in providing targeted, predictive and preventive solutions. Role of genomics has

Bu

gw

ork

s

One of the very few startups exploring drug discovery and development, Bugworks, is developing novel class of antibiotics designed to treat multi-drug resistant infections. The asset in pre-clinical stage addresses an urgent global need in treating next-generation anti microbials for superbugs. With several innovation awards in the kitty it is the first Indian venture funded by CARB-X accelerator. In addition to BIG, the venture is also supported by Baxter Ventures, 3one4 capital and Biocon.

Te

rge

ne

Tergene, a Hyderabad based innovation-led vaccine company is working on a novel multivalent Pneumococcal Conjugate Vaccine (PCV) that broadens the coverage of existing 13 valent vaccine and makes it more efficacious for the Asian subcontinent by identifying the predominantly existing strains for this region. Considering India has highest incidence of the disease with current 100% import dependence for the vaccine, Tergene’s indigenous candidate has the potential to break affordability barriers and alleviate the national disease burden.

Incozen Therapeutics: Example of venture catering to global market

Incozen is a clinical-stage biopharmaceutical company focused on discovery and

development of innovative, small molecule drugs that target signal transduction networks

and ion channels for the treatment of cancer, inflammation, autoimmune diseases and

metabolic disorders. The company was founded by ex-R&D head of Glenmark and

attracted strategic investment from Alembic. Their lead asset for oncology is currently in

Phase 3, advanced by TG Therapeutics, USA while the immune therapeutic product is

on-going Phase 1 clinical trial in partnership with Novartis.


17

expanded from rare genetic disorders to common diseases namely cancer, diabetes & stroke

and is emerging as a critical part of standard clinical workflow. There is an equal number of

ventures catering to B2B as well as B2C markets. Ventures like Mapmygenome, The GeneBox

and XCode are engaging in consumer focused genomic tests and products offering elective

choices for genetically tailored solutions in fitness, nutrition, skincare etc. At the other end,

ventures such as Strand Lifesciences and Mitra Biotech are pushing the envelope on clinical

horizons and engaging in identifying and offering test panels with proprietary markers.

Regenerative Medicine: Globally, regenerative therapies are witnessing wider acceptance

and escalating growth rates, with cell based products constituting the largest market share.

This global trend is reflected in Indian startup landscape as well, across cell therapies,

modified blood/tissue products, and gene therapy. Today, several autologous therapies are

commercially being offered but scale-up models for startups in autologous therapies is still

elusive. Therefore, many ventures are pursuing allogenic therapies as well due to ease of

commercial scale up. Hospitals have been one of the drivers of research in autologous

therapies. As illustrated below, despite gaps in regulatory framework and lack of clarity, there

has been significant startup activity:

2.4.4 Artificial Intelligence & Machine Learning

Prominent innovation trends in the segment include

Emerging use of 3D printing in medical applications across product development and

commercial manufacturing;

Increasing pursuit of drug device combinations for life cycle management and competitive

advantage;

Innovations in biomaterial expanding possibilities;

Pervasive use of robotics, artificial intelligence and machine learning for developing smart

devices and

Leveraging Internet of Things (IoT) to progress towards a more connected continuum of

care.

Eye

Ste

m R

es

ea

rch

Ahmedabad based venture

incubated at C-CAMP is

developing breakthrough cell

therapies for degenerative

diseases of the eye through a

combination of gene editing and

stem cells. Their unique

approaches are directed towards

creating cells that can evade

immune rejection, creating

scalable allogenic therapies and

also opening avenues for

treatment of other degenerative

therapies of the body.

Ne

xt

Big

In

no

va

tio

ns

La

bs

With 3D printing expanding

horizons of product development,

NBIL is working at the nexus of

engineering and biotechnology.

The team has developed a 3D

Bioprinter and in parallel working

on novel tissue mimicking material

composites to create 3D bio-

printed scaffolds for both in-vivo

and in-vitro uses. Their work will

find application in preparing

implants, training physicians for

complex surgeries, drug discovery

and others at an affordable price.


18


19

Era 3.0:

Recommendations for

Triggering Global

Impact

Recommendations for Triggering Global Impact

20

Era 3.0: Recommendations for Triggering Global Impact

The last decade has been foundational for the biotech innovation ecosystem in India. A surge

of startups has been commenced and entrepreneurs are motivated by availability of early

proof-of-concept funding. Current policy initiatives such as Make-in-India and Startup India

add to the momentum. As a country today, we have the invaluable opportunity of further

shaping this innovation led era and making our mark on the world with drugs, devices and

diagnostics invented and developed in India. However, as we chart Era 3.0, we need to

acknowledge that the path to markets in the case of lifescience startups is longer,

progressively more capital intensive, includes higher binary risk and is intrinsically more

complex. While we have strategically pieced certain pieces of the maze, several other critical

challenges stand it the way of realizing the true potential of biotech startups in India. It is critical

that we appreciate our unique contextual challenges and urgently design catalytic solutions to

foster a holistic and sustainable ecosystem for biotech startups and accomplish our Make-in-

India and Startup India goals.

3.1 Fostering More Robust Pipeline of Deep Science Driven Startups

3.1.1 Encouraging Greater Scientific Sophistication in Ventures:

India has distinctive specialism in frugal innovation and there has been great focus on

rethinking affordable solutions. While price economics is a precursor to innovation adoption in

the country, there is a simultaneous need to think beyond and pursue globally benchmarkable

science. For the innovation ecosystem to evolve and gain global prominence, it is important

we foster sophisticated and upstream scientific innovation, defensible IP portfolio, and

Addressing Continuing Challenges in Biotech Startup Ecosystem

Strengthening

Innovation Flows Creating Market

Pull


21

innovations with global market potential. There are a subset of ventures today that are

pursuing high complexity areas of innovation such as novel drug discovery, next generation

regenerative therapies, genomics and novel biomarker discovery, and novel medical devices.

However, these represent a very small cross-section of the current startup landscape with

majority focusing on incremental innovation. Having seeded initial momentum and an active

entrepreneurial ecosystem in biotech, it is critical that we focus on strategically expanding the

cohort of ventures pursuing deep-science led innovation pursuits. Raising the level of

selectivity for non-dilutive funding, incentivizing higher level of global collaborations, nurturing

scale-up funding avenues with greater risk appetite and celebrating a higher bar of science

could help create more globally comparable startups.

3.1.2 Leapfrogging Institutional Engagement in Translational Research

Globally, most breakthrough biotech and medtech innovations have originated in academic

labs and have been nurtured with non-dilutive government funding. When application potential

is more evident, innovation is often spun out into ventures that either advance the innovation

to markets or out-license to larger companies at later stages of development. The significance

of academia and biotech startups has expanded multifold with large pharma and medtech

companies’ increasing dependency on external

research. However, in the Indian context, very few

startups are spin-outs from academic research,

and research institutions are yet to emerge as

major drivers of upstream science with

commercial potential. To nurture a holistic

innovation ecosystem and a more evolved startup

landscape, it is important that institutions are

strategically engaged in this mission.

Several elements would need to be addressed to

create a formidable backbone of institutional

research that serves as base of the innovation funnel. We need to enhance the level of

institutional engagement in industry-relevant translational research. This will require

reimagining delineated research construct from innovation lens and fostering multidisciplinary

training across engineering, IT and basic sciences. Additionally, there is also great merit in

strategic allocation of part of the intra-mural funding to identify areas of translational research

where critical depth of engagement can be instated in concentrated institutional clusters.

Platforms for industry-academia engagement need to be multiplied and global translational

research collaborations need to be enhanced multi-fold. Finally, technology transfer capacity

needs to be created across institutions and mechanisms formulated to reward inventors for IP

creation, commercialization and monetization.

3.2 Addressing Glaring Void in Scale-up Funding

India today has a good foundation of seed and early proof of concept funding mechanisms

under the broader umbrella of DBT and DST, complemented by international grants,

philanthropic funding and state government resources. This has been highly empowering for

entrepreneurial aspirants and provides initial risk capital in a non-dilutive form. In product

segments with relatively shorter paths to market (such as certain medical devices and

During 1996-2015, academic

patents & subsequent licensing

to industry bolstered US industry

gross output by up to USD 1.33

trillion, GDP by up to USD 591

billion and supported up to

4,272,000 person years of

employment. The Economic Contribution of University/Non

Profit Inventions in United States: 1996-2015


22

diagnostics), entrepreneurs have

been able to leverage this early

proof of concept funding to

advance to a stage where equity

has been more accessible for

market entry and scale-up.

However, in more capital

intensive segments such as drug

discovery and Class III medical

devices, entrepreneurs have

highlighted the insufficiency of

the standard INR 50 lakhs seed

grant and 18 months grant

period. An alternative approach

would be to complement the

product and segment agnostic

seed grants with more tailored

seed grant programs for higher

risk and more complex

innovation pursuits.

Ease of access to capital ends at

this early proof of concept stage and ventures thereafter step into a deep valley of death

characterized with negligible level of early stage venture capital for high risk biotech

innovation. New drugs and vaccines in particular can take between 8 to 10 years to develop

and progressively need increasing amounts of capital as the asset is advanced through stages

of pre-clinical and clinical validation. Even the stepping stone of angel networks that have

provided early risk capital for technology ventures have been relatively unforthcoming for

biotech entrepreneurs. Even in the select cases where angel networks have invested in

biotech startups, there have been practical challenges such as misalignment of investment

horizon, lack of appreciation of product

development pathway, and decision

making challenges stemming from small

tranche of investment being pooled from

more than 20 angels. Based on the current

pipeline in India and continued venture

creation, we estimate that aggregate

investment required for developing

assets until stage of commercialization

is USD 6.2 Billion. The illustration

alongside depicts the approach for

quantifying such capital requirement.

This capital requirement is almost

completely unmet today, barring VC

appetite for lower risk devices and diagnostics. The Fund of Funds announced under Startup

India served as a beacon of hope – it includes an allocation of INR 10,000 crores for Securities

and Exchange Board of India (SEBI) registered Alternative Investment Funds (AIF). The

corpus will be disbursed over two finance commission cycles, with the first allotment of INR

Indicative global model – South Korea is a

good global reference given the transformation

from a domestically focused generics industry to

a strong innovation force with USFDA and EMA

approved drugs. Building blocks inducing such

transformation include:

KDDF- a USD 1.5 billion Government fund,

providing grants to drug development

companies with the aim of creating 10

blockbuster drugs by year 2020.

NASDAQ like exchange where innovation led

companies can list pre-revenue based on a

technology assessment.

Fiscal benefits for R&D pursuits as well as

technology or corporate acquisitions.

A VC ecosystem with flexibility to invest in

international companies to create sustainability

while domestic pipeline strengthens.


23

600 crore to 17 AIFs already in place. 75 Startups have received funding from these AIFs.

Notably, most of these funds are concentrated in early stage technology investment, an area

that already enjoys significant VC interest. Barring the Karnataka Government’s KITVEN fund

and agribusiness centric Omnivore, no other fund has a stated focus on early stage

lifesciences. Even these are focused on smaller investments and no fund granted intends to

participate in the gap area of $5 Million to $20 Million product development investment for

biotech innovation in new drugs and vaccines. A welcome change was made in May 2017

when the definition of a startup was expanded from 5 years to 10 years for biotech startups.

However, this change has not resulted in any significant increase in allotment of funds to VCs

strategically focused on biotech. Inadequacy of scale-up funding is pushing cream of biotech

ventures to re-domicile themselves in more evolved innovation hubs such as US, Singapore

and Switzerland thereby shepherding innovation outside of India, drain of potential economic

value or worse still, leading to venture mortality.

Need for catalytic Government investment in VC funds is most needed in areas where the void

is deepest and has significant economic and social repercussions. Ideally, part of this Fund of

Funds should be strategically allocated to biotech risk capital and should yield multiplier impact

on private investments to urgently bridge this capital deficiency and avert venture mortality or

fleet of high potential ventures from India.

Funding Requirement across Startup Lifecycle


24

Vitas Pharma:

Entrenched in the area of

drug discovery and

development, Vitas pharma

is developing next-

generation antibiotics to

treat multidrug resistant

hospital acquired

infections, started as boot-

strapped venture in 2011,

the company was later

supported by BIPP and BIG

programs and received

equity investment from IAN.

Co-founded by Radha

Rangarajan and Rajinder

Kumar, Vitas pharma is

incubated at TBI at

University of Hyderabad.

Innovator’s Perspective

“The Indian biotech sector is characterized by

incremental innovation, focused mainly on

lowering the cost of products for the Indian

consumer. Such product development has

greatly benefited the Indian consumer but

disproportionate investment in such product

development leaves the country vulnerable to

problems that are uniquely Indian or are low

priority for MNCs.

A very small segment of the biotech sector is

focused on innovative R&D, aimed at developing

novel products. Unfortunately, this segment

remains perennially under-capitalized. Many

reasons are cited for this, including the risk

appetite of the investors, quantum of capital

required and product development timelines.

Although successful products will deliver

significant upside to the investor, the lack of

such examples has discouraged investment.

Thus the sector is trapped in a chicken-and-egg

deadlock. A concerted effort bringing public and

private investment sources is necessary to

emerge from this impasse and give Indian

entrepreneurs a chance to succeed.”

Dr. Radha Rangarajan: Co-Founder, Vitas Pharma &

Member, CII National Committee of Biotechnology

3.3 Continuing Infrastructure Challenges at Scale-up Stage

Biotech and medtech ventures require specialized infrastructure and incubation facilities. DBT

and DST have both supported creation of several incubators with common infrastructure

required for lab scale research. Most entrepreneurs have indicated a high level of satisfaction

with availability of basic infrastructure. While there still remains a dearth of design, prototyping,

fabrication and validation facilities for medical devices, these are being bridged with additional

facilities currently being created across various cities.

However, ventures face significant infrastructure hurdles once they cross lab scale proof of

concept and need to scale up to pilot scale. At this stage, most ventures require cGMP facilities

to produce preclinical and clinical trial batches – an area where capacity in the country is close

to non-existent. For example, several incubators have a 5 liter fermenter and lab scale facility

where initial proof of concept can be generated, however biopharma products often need to

be scaled up to about 100 liters at the next stage with cGMP compliance required for preclinical

and clinical batches. Subsequently at a commercial scale, the molecules need to be further

scaled up to a 200 liter to 3000 liter scale. Dearth of capital makes it close to impossible for


25

them to build their own facilities and outsourced services of the required quality are often

unaffordable for cash strapped ventures to access. This converges with the valley of death

stage when capital needs multiply as the program moves into preclinical and clinical validation.

Akin to the capital access challenge, this infrastructure hurdle occurs at a time when significant

value inflexion points are a few critical steps away but are elusive until preclinical and clinical

milestones are accomplished. In addition to the ultimate threat of a mortality challenge, this

infrastructure hurdle also leads to inordinate delays in program execution and erosion of value

due to loss of contemporariness of the program. As India’s biopharma pipeline is gradually

maturing, more and more ventures are advancing to this critical stage and the need to address

this infrastructure gap on an urgent basis is higher than ever.

Infrastructure and ecosystem gaps at the scale up stage are present in the medtech segment

as well but ventures often address the problem by seeking service providers in US, Germany

or China. Given the relatively lower capital needs in the medtech segment, infrastructure is a

smaller threat to sustainability, but calls for early attention to ensure a stronger domestic

ecosystem. Additionally, to cultivate engagement in more complex areas of medtech

innovation, there is a need for specialized design, prototyping and validation infrastructure

such as nanofabrication facilities, advanced 3D printing platforms, simulated validation centers

for implants that could potentially be nurtured via international institutional partnerships that

enjoy strength in these specific platforms. Creation of such infrastructure and technical

platforms will be very important to steer the medtech innovation ecosystem into the next realm

of complexity, sophistication and economic value creation. The BIRAC i3 program is a major

step recently initiated to address this challenge and more such efforts are essential in the near

future.

3.4 Creating Reward for Innovation and Fostering Market Maturity

At the end of the complex innovation continuum, realization of potential impact as well as

creation of economic value finally depends on widespread innovation down streaming.

Commercialization success is also fundamental for sustainability at both the venture and

ecosystem level. To this end, two elements that need to be championed are market maturity

and reward for innovation. While affordability and equitable access are of paramount

importance for India, it is also essential that we pursue strategic models that also ensure

reward for innovation.

In the case of drug discovery and development, level of investment is significant, lead time is

long and risks are high. Drug pricing policy and market access for public healthcare needs to

evolve to provide optimal incentive for innovators while ensuring healthcare access.

Medical devices and diagnostics startups, on the other hand, face the threat of very immature

and fragmented markets where established scale-up pathways don’t exist. It is noteworthy

that the number of large Indian companies in the segment with revenues north of INR 100

crore are far and few with the exception of companies engaged in consumables or other low

tech products. Mature channel partners and scale-up models that can be emulated do not

exist.


26

Realizing optimal

and sustainable

price economics

As the Indian industry landscape grows beyond small molecule generics

and low tech consumables in the case of medical devices with expanding

innovation engagement, policymakers need to adjust the lens with which

they view drug and device pricing. Pricing is a complex subject given the

often-conflicted objectives of ensuing reward for industry and ensuring

healthcare access. There has been widespread industry concerns

around extensive use of price capping on drugs and now medical devices

as well. It may be a justifiable approach for genericized and commoditized

products but is inappropriate in the case of any innovative drug, device

or diagnostics and can completely dampen the innovation momentum.

While value based healthcare pricing approaches may be harder to

implement in the Indian system with more than 70% out of pocket

spending, alternative solutions such as cross-subsidization as

exemplified by the Vaccine industry are great models to consider in the

Indian context. Indian vaccine industry is a recognized manufacturing

success story steered by high level of success in innovation absorption.

In this case, affordable supply for Indian and global public immunization

has been accomplished by concerned efforts at two critical ends -

substantial pooling of volumes in the public system driving volume based

price economics, and flexibility to price in private markets allowing for

cross-subsidization.

Facilitating rapid

scale-up across

market channels:

Public

Procurement

In addition to optimal pricing, pathways for rapid scale-up and innovation

absorption is also critical for sustainability. The lack of transparency in

public and private procurement channels is way more complex than it

appears on the surface. The dampening effect is more brutal in the case

of innovations for public healthcare problems where there is greater

dependency on public procurement for market creation – case in point is

at least handful of maternal and child health innovations and TB

diagnostic products that haven’t translated to commercial success as

they still await public health attention and adoption. While NHSRC had

rolled out a health technology assessment mechanism to support

innovation adoption in public health, startups have indicated no tangible

progress through the intended pathway. It is critical we create and

effectively implement adoption and procurement mechanisms for

innovation in public health. Even in the case of products already procured

for public health, public markets continue to remain highly fragmented

given the nature of de-centralized procurement, with even individual

hospitals putting out tenders in several cases. There has also been a

historical challenge of public tenders calling for CE marked and FDA

cleared devices.


27

Facilitating rapid

scale-up across

market channels:

Private Markets

In the case of drugs, there is an incumbent advantage of several large

companies with strong sales and marketing presence that could be

potential partners for down streaming innovation. However, most of these

are generics companies with low appetite currently to nurture innovative

product portfolios. While a gradual shift is envisioned in innovation focus

of larger companies, this change needs to be fostered in an accelerated

way through appropriate policy mechanisms. This is important for

nurturing a holistic innovation ecosystem where research institutions,

startups and larger companies can work synergistically to develop

innovations and deliver them to markets. While there has been R&D

benefit on in-house R&D expenditure and there is now a lower tax rate

for royalty revenue on Indian patents for the out-licensing entity,

incentives for larger companies to absorb innovation through licensing or

acquisition should also be provided. This will catalyze initial industry

engagement and evolving market maturity will sustain the momentum.

In the case of medical device and diagnostics, market channels are

underdeveloped for most product categories and more so for innovative

ones. Private markets are highly fragmented and channel partners are

distributors of sub-optimal size and reach, with no experience in concept

selling. Several private hospitals have a preference for higher priced

products as it allows them to increase their billing. There is a severe

dearth of large domestic companies that can be commercialization

partners. Transparency of pricing needs to be instigated across the

supply chain and value based reward needs to be long term goal vs price

capping of individual inputs. In the near term, the healthcare delivery

ecosystem needs to be sensitized, incentivized to deliver high quality

care and adopt innovation tools to that end. To create reward for

innovation for medical devices, policy intervention needs to begin at level

of healthcare delivery, especially given the greater focus on private sector

involvement in the National Health Policy.

3.5 Ease of Doing Business

India this year jumped 30 notches to secure the 100th spot in World Bank’s ‘ease of doing

business’ ranking. There have been several positive developments that have benefited the

biopharma and medtech segments including startups – notably, import of biomaterials for

research use is now easier, there is greater regulatory clarity for biosimilars with introduction

of the new guidelines, certain regulatory changes as requested by the industry has been

initiated for vaccines and most importantly the medical device rules have been introduced.

While the strategic focus and progress is very encouraging, there continue to remain concerns

specific to biotech startups that are outlined below:

3.5.1 Enhancing clarity on policy and regulations

Bridging gaps in regulatory frameworks and simplifying processes: A significant

continuing impediment is the regulatory headwinds and timeline in accessing raw materials,

getting timely product approvals and penetrating markets. Although norms for import and

export of human biological samples have been relaxed since 2016 with no license


28

requirement, there remains plenty that needs to be done. Specific issues that most affect

startups in biotechnology and lifesciences include:

Continuing inverse duty structure for medical devices – while inverse duty structure

problem has been addressed in certain medical device products, it continues to erode

competitiveness of Indian product developers and manufacturers in several product

categories where inputs and components have higher duty structure than final product.

Regulatory lacuna in regenerative medicine and rare diseases, with poor regulatory

awareness overall – Within the subset of startups that are pursuing more complex and

globally benchmarkable innovation, there are ventures engaged in therapeutics for rare

diseases, next generation solutions such as gene therapy and emerging areas of

regenerative medicine. While India does have a guideline for stem cell therapies, there is

significant gap in the overall landscape of possibilities under regenerative medicine –

modified blood and tissue products, cell therapy (autologous and allogenic) as well as

gene therapy. While there are therapy options now emerging in the global context, the

price of these therapies (more than USD 500,000 per patient) make them prohibitive in the

Indian context and it is extremely critical that we provide wings to domestic ventures

pursuing breakthroughs in these areas. Additionally, most startups have poor awareness

about regulatory implications and pathways for market access within and outside India,

calling for multifold expansion in capacity building efforts in this area.

Need to expand Access to regulators and formalize a time bound official response

system – Given efforts made by DCGI, CDSCO, CDSA etc., there is greater accessibility

of regulators now and several ventures have had the opportunity to interact with CDSCO

officials at workshops or other events. Avenues for such access should continue to be

created to further enhance this perception. Additionally, it is recommended that

mechanisms are created for requesting formal meetings with regulators at various

milestones of clinical development with a need for time-bound dispensation of such

requests akin to possibilities with USFDA and EMA.

Breaking the regulatory uncertainty and inactivity in agri-biotechnology – Lastly,

there have been several pioneering startups in India in the agri-biotechnology domain that

either faced sustainability risks or have been forced to shift focus to less scientifically

complex areas with no regulatory uncertainty. There is also a strong pipeline from Indian

public research institutions with significant potential for economic impact. Biotechnology

can help achieve India’s goals for doubling farmers’ income and with a robust regulatory

pathway, can enhance competitiveness of several industries in the food and feed value

chain. For instance, potential of poultry exports from India is attenuated as global

counterparts with access to GM corn for feed enjoy significantly greater competitiveness.

Startups in the agri-biotechnology segment have pursued globally benchmarkable

science, and de-regulation will be critical for their resurrection.

3.5.2 Creating a pro-IP perception in the global context

India has also long battled global perception of poor IP policy & enforcement and often touted

to be non-compliant with the minimum standards set by TRIPS. A couple of legal decisions

pertaining to Section 3(d) of the Indian Patents Act, 1970 and compulsory licensing caused

significant damage to the country’s reputation. However, the perception is often harbored

without awareness of details of either legal cases or circumstantial context. Section 3(d) is a

debatable subject and the country’s concerns on misuse for ever-greening needs to be

appropriately articulated. While India’s dominance in generics is widely known, there is limited


29

recognition of the evolving landscape of IP creation in the country. Similarly, there is also

limited awareness of positive capacity enhancements augmented with changes in functioning

of the Indian Patent Office.

While the poor IP and often negative IP perception is a challenge for the industry as a whole,

it is a significantly larger problem for startups whose entire value rests on their innovation

pursuits. This challenge impacts their prospects at several milestones and results in hardship

in raising investments from international investors or pursuing global strategic partnerships for

asset licensing or co-development. Despite such negative perception, startups that attract

interest of global investors on the strength of their innovation program, are often asked to

engage in IP inversion and re-domicile their IP assets in a different geography such as

Switzerland, US, UK or Singapore based on investor preference. If innovation is to be nurtured

in startups or larger companies and innovation led growth is to be pursued, India needs to

urgently change the perception around unreliability and inadequacy of the IPR policy, and

create awareness around the quality of innovation pipeline.

3.5.3 Making tax regime more globally competitive

To harbor a holistic innovation ecosystem, fiscal benefits need to evolve further to incentivize

and reward continued momentum, and be globally comparable with successfully catalyzed

innovation hubs such as South Korea and Switzerland. It is also important that such incentives

apply to innovation pursuits through both pathways - in-house or in-licensed/acquired

programs. Engagement in India needs to be strengthened across the continuum of lab to

markets and there is merit in encouraging in-house discovery and development as well as

optimal portfolio building through balance of in-house R&D and in-licensed programs.

Lowering of tax incentive on in-house R&D expense was a disappointing development for the

industry. While the lower tax rate on out-licensing revenue of Indian patents was a welcome

development, it is restrictive due to applicability to only ‘Indian patents’ and only on royalty

revenue from out-licensing.

Additionally, it is also vital to sync fiscal benefits with high thrust programs such as Startup

India. A case in point is a challenge sighted by several biotech startups –DSIR registration is

required for availing benefit of zero customs and excise duty on capital equipment purchased

for research and being eligible for several Government funding programs. However, until the

startup has been operational for at least 3 years, it doesn’t qualify for DSIR registration. Hence,

access to grants beyond INR 50 lakhs is a challenge for startups during the first three years

and part of the funds accessed get further drained for payment of duties on R&D equipment.

We have come a long way from combating fundamental challenges like inadequate

infrastructure, capital scarcity, suboptimal resources and brain drain to today boasting a rich

domestic pipeline of biotech innovation. But there remains a huge potential that can be and

needs to be harnessed. Strengthening core capacities in existing institutes, dedicated

technology transfer cells, creating the right infrastructure for curating idea, providing funding

across all stages of innovation lifecycle; and developing efficient reimbursement models for

innovation absorption will be the key determining factors for accelerated growth of the industry.

Transition from Era 2.0 to Era 3.0 heavily rests on synchronizing resources, plans, policies

and priorities with a vision to build sustainable and structured model.


30


31

Abbreviations

32

Abbreviations

ACE Fund Accelerating Entrepreneurs Fund

ACR Albumin Creatinine Ratio

AIF Alternative Investment Funds

AIIMS All India Institute of Medical Sciences

BERA Brainstem Evoked Response Audiometry

BIG Biotechnology Ignition Grant

BIPP Biotechnology Industry Partnership Programme

BIRAC Biotechnology Industry Research Assistance Council

BISS Bio-Incubator Support Scheme

BMT Wing Biomedical Technology Wing

BRIC BIRAC Regional Innovation Centre

C-CAMP Centre for Cellular and Molecular Platforms

CDSA Clinical Development Services Agency

CDSCO Central Drugs Standard Control Organization

CEFIPRA Indo-French Centre for the Promotion of Advanced Research

CRS Contract Research Scheme

CSIR Council of Scientific & Industrial Research

CTCs Circulating Tumor Cells

DBT Department of Biotechnology

DCGI Drug Controller General of India

DPRP Drugs and Pharmaceuticals Research Programme

DSIR Department of Scientific and Industrial Research

DST Department of Science & Technology

EMA European Medicines Agency

FDA Food and Drug Administration

FITT Foundation For Innovation And Technology Transfer

GCI Grand Challenges India

GDP Gross domestic product

GITA Global Innovation & Technology Alliance

GLP Good laboratory practice

HITC Healthcare Technology Innovation Centre

HTIC The Healthcare Technology Innovation Centre

IAN Indian Angel Network

ICAR Indian Council of Agricultural Research

ICGEB International Centre For Genetic Engineering And Biotechnology

ICMR Indian Council of Medical Research

IISc Indian Institute of Science

IISER Indian Institute of Science Education and Research

IIT Indian Institutes of Technology

IITM Indian Institutes of Technology Madras

INR Indian Rupee

IoT Internet of Things

IP Intellectual Property

33

IPR Intellectual property rights

ITVUS India Technology Venture Unit Scheme

JNCASR Jawaharlal Nehru Centre for Advanced Scientific Research

KDDF Korea Drug Development Fund

KITVEN Karnataka Information Technology Venture Capital

KSIDC Kerala State Industrial Development Corporation

NARI National AIDS Research Institute

NBA National Biodesign Alliance

NCBS National Centre for Biological Sciences

NCCS National Centre for Cell Science

NCL National Chemical Laboratory

NHSRC National Health Systems Resource Centre

NIDHI National Initiative for Developing and Harnessing Innovation

NITI Aayog National Institution for Transforming India Aayog

NIV National Institute of Virology

NMITLI New Millennium Indian Technology Leadership Initiative

NSTDEB National Science & Technology Entrepreneurship Development Board

OSDD Research on open source discovery of drugs

PCV Pneumococcal Conjugate Vaccine

PoC Point of Care

PRAYAS Pre-incubation initiative and a source of pipeline for incubators

PRISM Promoting Innovations in Individuals, Startups and MSMEs

R & D Research and development

RCB Regional Centre for Biotechnology

SBIRI Small Business Innovation Research Initiative

SCTIMST Sree Chitra Tirunal Institute for Medical Sciences and Technology

SEBI Securities and Exchange Board of India

SEED Fund Sustainable Entrepreneurship and Enterprise Development Fund

SIB Stanford-India Biodesign

SMEs Small and medium-sized enterprises

SPARSH Social Innovation Programme for Products Affordable & Relevant to Societal Health

STEP Science and Technology Entrepreneurs Parks

TBI Technology Business Incubators

TDB Technology Development Board

THSTI Translational Health Science & Technology

TRIPS Trade-Related Aspects of Intellectual Property Rights

UAS University of Agricultural Sciences

UIC University Innovation Cluster

USD United States Dollar

VAP Vaccine Action Programme

VC Venture Capital

WHO World Health Organization

35

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conducive to the development of India, partnering industry, Government, and civil society,

through advisory and consultative processes.

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